MORRIS PLAINS, N.J., Oct. 20 /PRNewswire-FirstCall/ -- Immunomedics, Inc.
(Nasdaq: IMMU) announced today that the Company plans to study the safety and
efficacy of epratuzumab in registration trials in patients with systemic lupus
erythematosus (SLE).
Following the Company's announcement yesterday of a successful meeting
with FDA, in which Phase II data were reviewed and the design of registration
trials was presented, the Company plans to formally file the agreed upon
protocols and to begin enrolling patients into these registration trials in
the near future.
"We are pleased to move this product forward into pivotal trials,"
commented Cynthia L. Sullivan, President and Chief Executive Officer. "We
expect to consult with the European regulatory authorities, and plan to
initiate clinical trial sites in the United States, Europe and Canada."
In addition, the Company is also planning later registration trials with
epratuzumab in patients with non-Hodgkin's lymphoma, having already determined
pivotal trial design with FDA and the European regulatory authorities.
Immunomedics, Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of diagnostic imaging and
therapeutic products for the detection and treatment of cancer and other
serious diseases. Integral to these products are highly specific monoclonal
antibodies and antibody fragments designed to deliver radioisotopes and
chemotherapeutic agents to tumors and other sites of disease. Immunomedics
has therapeutic product candidates in clinical development and has two
marketed diagnostic imaging products. Our most advanced therapeutic product
candidate is epratuzumab, for which certain Phase II clinical trials for the
treatment of non-Hodgkin's lymphoma have already been completed.
This release, in addition to historical information, contains forward-
looking statements made pursuant to the Private Securities Litigation Reform
Act of 1995. Such statements, including statements regarding clinical trials,
involve significant risks and uncertainties and actual results could differ
materially from those expressed or implied herein. Factors that could cause
such differences include, but are not limited to, risks associated with new
product development (including clinical trials outcome and regulatory
requirements/actions), competitive risks to marketed products and availability
of financing and other sources of capital, as well as the risks discussed in
the Company's Annual Report on Form 10-K for the year June 30, 2004. The
Company is not under any obligation, and the Company expressly disclaims any
obligation, to update or alter any forward-looking statements, whether as a
result of new information, future events or otherwise.
Company Contact: Chau Cheng, Associate Director, Investor Relations &
Business Analysis, (973) 605-8200, extension 123. Visit the Company's web site
at http://www.immunomedics.com.
SOURCE Immunomedics, Inc.
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Chau Cheng, Associate Director, Investor
Relations & Business Analysis, Immunomedics, Inc.,
+1-973-605-8200, ext. 123
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